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FDA 510(k)

FPR GENTAMICIN CALIBRATOR KIT

K-Number: K894524 · 1989-09-28

ApplicantColony Laboratories, Inc.
Decision Date1989-09-28
Product CodeDLG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

FPR GENTAMICIN CALIBRATOR KIT is the device name listed in this FDA 510(k) record. The listed applicant is Colony Laboratories, Inc.. It received FDA 510(k) clearance on 1989-09-28 under 510(k) number K894524. The device is classified under product code DLG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FPR GENTAMICIN CALIBRATOR KIT?

FPR GENTAMICIN CALIBRATOR KIT is a medical device that received FDA 510(k) clearance on 1989-09-28. The listed applicant is Colony Laboratories, Inc.. The 510(k) number is K894524.

When did FPR GENTAMICIN CALIBRATOR KIT receive FDA 510(k) clearance?

FPR GENTAMICIN CALIBRATOR KIT received FDA 510(k) clearance on 1989-09-28, under 510(k) number K894524.

Who is the listed applicant for FPR GENTAMICIN CALIBRATOR KIT?

The FDA 510(k) record lists Colony Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FPR GENTAMICIN CALIBRATOR KIT?

The FDA product code for FPR GENTAMICIN CALIBRATOR KIT is DLG.

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Other records listing Colony Laboratories, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K894523FPR GENTAMICIN KITK894518FPR AMIKACIN CALIBRATOR KITK894517FPR AMIKACIN KITK894528FPR PHENYTOIN CALIBRATOR KITK894527FPR PHENYTOIN KITK894521FPR DIGOXIN KIT

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Related Devices (Code: DLG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K050988OPIATE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLSLin-Zhi International, Inc.K920419IL TEST DAT CAL/CONTROL SET D/EInstrumentation Laboratory COK894518FPR AMIKACIN CALIBRATOR KITColony Laboratories, Inc.K894528FPR PHENYTOIN CALIBRATOR KITColony Laboratories, Inc.K882766EMDS ACETAMINOPHEN CALIBRATOR NO. 67636/95Em Diagnostic Systems, Inc.K833385N-ACETYLPROCAINAMIDE CALIBRATORE.I. Dupont DE Nemours & Co., Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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